Former FDA Commissioner weighs in on mifepristone case
Judges will hear arguments next month on whether the pill should remain on the market amid jurisdictional conflicts between FDA, state law
A group of former commissioners of the Food and Drug Administration filed an Amicus Brief in the medication abortion lawsuit currently being considered by the Supreme Court.
The Supreme Court is set to hear arguments in the case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, on March 26. In their brief, the FDA commissioners drew on their expertise to show the FDA’s merits in approving drugs. Ultimately, they hope the court defers to the agency in federal drug regulation.
Jane Henney, who led the FDA from 1999 to 2001, spoke to me about their brief and the potential implications of this litigation.
“The FDA has the appropriate panels of physicians and scientists to do this kind of review and make these kinds of determinations, too,” Henney said. “And I think it's not just the final decision about approval. It's all of the multitude of decisions that have to be made by experts based on the evidence all along the way. I just do not believe that the courts are equipped to do that.”
Henney oversaw the approval of mifepristone, which is the drug that is currently being reviewed by the court to see if it should be allowed on the market. Experts reviewed the drug for four years. They saw it as a priority drug because it was the first in its class, but it wasn’t rushed. It underwent the same rigorous process as every other drug.
“It's a very strict, it's a very tedious, it's a very complex process,” Henney said.
There had been a restriction by the FDA requiring a physician to prescribe the drug. But as time went on, and they learned more about the drug, those restrictions lessened.
“That’s what happened originally, not what necessarily is appropriate for now that we've got 20 years of experience with a drug,” Henney said. “And some of those restrictions were demonstrated by clinical trials and other means that they were no longer necessary.”
Another potential consequence of this decision will be its effect on drug manufacturers' investments in developing and producing medicines. Henney suspects they will be reluctant in many areas, perhaps in reproductive medicine.
“They need predictability because they invest for the long term in a drug they count on,” Henney said. “This standard that the FDA uses to review is really known as the gold standard because it's based on scientific evidence.”
The brief is below.
